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A joint FDA advisory committee voted against recommending approval of Intellipharmaceutics’ extended-release opioid painkiller Rexista, as well as against the claim that it deters abuse. Read More
Celgene reached a civil settlement with the Department of Justice and 28 states, as well as Washington D.C. and the city of Chicago, agreeing to pay $280 million to resolve a case over off-label marketing claims for two cancer treatments — Thalomid (thalidomide) and Revlimid (lenalidomide). Read More
FDA Commissioner Scott Gottlieb sought to assure agency staff this week that Congress will reauthorize its user fee programs before the Sept. 30 deadline, which promise to provide the agency more than $1.4 billion in funding for reviewing activities and staff salaries in the next fiscal year. Read More
France’s Agency for the Safety of Health Products cited Chinese API manufacturer Chongqing Succeway Pharmaceutical for GMP non-compliance, including one critical finding — active tampering with company data. Read More
Missouri Gov. Eric Greitens (R) directed his health department to begin building a state prescription drug monitoring program to track prescribing and dispensing of several controlled drugs, including opioids. Read More
In the first trial verdict of thousands of similar suits, a federal jury ordered AbbVie to pay $150 million to a man who claimed the company’s testosterone drug AndroGel caused his heart attack. Read More
With just over two months left in the program, the FDA finalized a question-and-answer guidance for GDUFA I, covering ANDA reviews, inspections and self-identification of facilities. Read More